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Studies to Assess Ziftomenib in Combination With Ven+Aza or 7+3 in Patients With Untreated NPM1-m or KMT2A-r AML
Sponsor: Kura Oncology, Inc.
Summary
Ziftomenib is an investigational drug in development for the treatment of patients with acute myeloid leukemia (AML) with eligible genetic alterations. Ziftomenib is a type of therapy known to target the menin pathway in cancer cells. This protocol has 2 separate studies that will investigate the benefits and risks of adding ziftomenib to standard-of-care (SOC) AML treatments in patients with certain genetic mutations who have not received any treatment for their AML. In the first study, the Nonintensive Therapy Study, older patients or those with serious medical problems will receive the SOC therapies venetoclax (ven) and azacitidine (aza), plus either ziftomenib or a placebo. In the second study, the Intensive Therapy Study, medically fit patients will receive (a) the SOC therapies cytarabine and daunorubicin, plus either ziftomenib or a placebo during a first treatment phase called induction, (b) cytarabine plus either ziftomenib or a placebo during a second treatment phase called consolidation, and (c) ziftomenib or a placebo during a third treatment phase called maintenance. The physician will determine which study is the appropriate treatment for the patient, but neither the patient nor their physician will know whether the patient has been assigned to receive ziftomenib or a placebo. This design is called "double-blinded".
Official title: Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1300
Start Date
2025-09-26
Completion Date
2031-11
Last Updated
2026-05-12
Healthy Volunteers
No
Conditions
Interventions
Ziftomenib
Oral administration
Placebo
Oral administration
Venetoclax
Oral administration
Azacitidine (AZA)
Intravenous or subcutaneous administration
Daunorubicin
Intravenous administration
Cytarabine (Ara-C)
Intravenous administration
Locations (53)
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States
University of California, Fresno
Clovis, California, United States
University of California, San Diego
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
University of California, Los Angeles
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of Colorado
Aurora, Colorado, United States
Colorado Blood Cancer Institute
Denver, Colorado, United States
Hartford HealthCare Cancer Institute
Hartford, Connecticut, United States
Yale University School of Medicine
New Haven, Connecticut, United States
University of Miami
Miami, Florida, United States
Moffitt Cancer Center & Research Institute
Tampa, Florida, United States
University of Kentucky
Lexington, Kentucky, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Rutgers Biomedical and Health Sciences
New Brunswick, New Jersey, United States
University of New Mexico
Albuquerque, New Mexico, United States
State University of New York at Buffalo
Buffalo, New York, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medical Center
New York, New York, United States
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University
Columbus, Ohio, United States
Willamette Valley Cancer Institute
Eugene, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Baptist Clinical Research Institute
Memphis, Tennessee, United States
Tennessee Oncology
Nashville, Tennessee, United States
TriStar Centennial Medical Center
Nashville, Tennessee, United States
Texas Oncology-Austin Midtown
Austin, Texas, United States
Texas Oncology-Presbyterian Cancer Center
Dallas, Texas, United States
University of Texas
Houston, Texas, United States
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States
University of Virginia School of Medicine
Charlottesville, Virginia, United States
Virginia Cancer Specialists
Manassas, Virginia, United States
WVU Medicine Wheeling Hospital
Wheeling, West Virginia, United States
University of Wisconsin
Madison, Wisconsin, United States
Froedtert & Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centre Hospitalier de Béziers
Béziers, France
Groupe Hospitalier de la Region de Mulhouse et Sud Alsace Hôpital Emile Muller
Mulhouse, France
Centre Hospitalier Universitaire de Nantes
Nantes, France
Centre Hospitalier Universitaire de Saint Etienne
Saint-Priest-en-Jarez, France
Centre Hospitalier Régional et Universitaire de Nancy Hôpitaux de Brabois
Vandœuvre-lès-Nancy, France
Helios Klinikum Bad Saarow
Bad Saarow, Germany
L'IRCCS Azienda Ospedaliero - Universitaria di Bologna
Bologna, Italy
Hospital de Braga, Centro Clínico Académico de Braga
Braga, Portugal
Dong-A University Hospital
Busan, South Korea
Chungnam National University Daejeon Hospital
Daejeon, South Korea
Chonnam National University Hwasun Hospital
Hwasun, South Korea
Ulsan University Hospital
Ulsan, South Korea
Hospital Universitario 12 de Octubre
Madrid, Spain
University Hospital Virgen Del Rocio S.L.
Seville, Spain
Hospital Universitario Y Politecnico La Fe
Valencia, Spain